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Category
Standard
Type
Standard
Version
2
Access
Open
Status
Active
Created
2013
This standard sets out the requirements that apply to tests for detecting, characterising and quantifying nucleic acids (DNA and RNA) in medical pathology laboratories that test for microorganisms that can or may cause disease in humans.

Main sections:

- Pre-analytical phase

- Specimen suitability and collection

- Laboratory facilities

- Analytical phase

- Validation and verification of NAT assays

- Characterisation including genotyping and resistance testing

- Conflicting tests and possible contamination

- Post-analytical phase

- Template for molecular testing validation for an in-house assay (informative)

- Verification of a commercial NAT assay (informative)
Access Requirements for medical testing of microbial nucleic acids

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